Maquet Cardiovascular, LLC: The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

Agency Publication Date: July 31, 2023

Affected Products

Product: ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S. Component of a chest stabilization system for cardiac and chest surgery.

UDI-DI: 00607567700536

Product: ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.

UDI-DI: 00607567700581

Product: ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization system for cardiac and chest surgery.

UDI-DI: 00607567700215

Product: ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.

UDI-DI: 00607567700543

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92446

Status: Active

Manufacturer: Maquet Cardiovascular, LLC

Manufactured In: United States

Units Affected: 4 products (785 units; 401 units; 594 units; 334 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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